Role of Colchicine as Anti-Inflammatory Therapy in HFpEF
NCT06837623 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75
Last updated 2025-02-25
Summary
Heart failure with preserved ejection fraction (HFpEF) is a condition associated with high morbidity and mortality. Chronic low-grade inflammation plays a key role in its progression, yet few treatments specifically target this pathway.
This clinical trial aims to evaluate the effectiveness of colchicine, a well-tolerated anti-inflammatory drug, in reducing inflammation in HFpEF patients. The study will assess whether colchicine lowers levels of soluble ST2 (sST2), a biomarker linked to inflammation and cardiac stress in HFpEF.
Participants will take colchicine daily for three months, with blood samples collected at baseline and at the end of the study to measure changes in sST2 levels. The findings could provide new insights into the potential role of colchicine as a treatment for HFpEF.
Conditions
- HFpEF - Heart Failure With Preserved Ejection Fraction
Interventions
- DRUG
-
Colchicine Tablets
Oral colchicine tablets. The dosing regimen is as follows: * Patients weighing \>70 kg: 0.5 mg twice daily (BID) * Patients weighing ≤70 kg: 0.5 mg once daily (OD) Administered for 3 months
Sponsors & Collaborators
-
Cairo University
lead OTHER
Principal Investigators
-
Magdy Abdelhamid Abdel Aziz, Professor of Cardivascular M · Cairo University
-
Ahmed Kamal, MD in Cardiology · Cairo University
-
Nesrine M El Gharbawi, Prof of clin. & Chem Patho · Cairo University
-
Shaima M Zeyad, Cardiology Resident · Cairo University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2025-02-22
- Completion
- 2025-03-01
Countries
- Egypt
Study Locations
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